Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PVRV · 1 trial · 1 indication
Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Patients with WHO Category II exposure receive PEP with PVRV using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later |
| Group 2 | EXPERIMENTAL | Patients with WHO Category III exposure receive PEP with PVRV using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab®, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later |
| Group 3 | ACTIVE_COMPARATOR | Patients with WHO Category III exposure receive PEP with PVRV using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later |
| Name | Type | Description |
|---|---|---|
| PVRV | BIOLOGICAL | 0.1 mL, 4 site 'one week' (4-4-4-0-0) administered intradermally |
| PVRV and pERIG Favirab® | BIOLOGICAL | 0.1 mL of vaccine administered intradermally in 4 site 'one week' (4-4-4-0-0) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s) |
Inclusion Criteria: For all patients: * Patient aged ≤50 years, with WHO category II or III contacts happened within 48 hours before appearance at site. For adults: * Informed consent form has been signed and dated. * Able to attend all scheduled visits and to comply with all trial procedures. ...
PVRV is a monoclonal antibody being developed for rabies post-exposure prophylaxis. It is currently in Phase 3 clinical development as an investigational therapy. The drug is being studied in a clinical trial in the Philippines to evaluate its immunogenicity and safety in a one-week intradermal regimen.
Sanofi (ticker: SNY) is developing PVRV. The company is conducting a Phase 3 clinical trial of the drug for rabies post-exposure prophylaxis. The trial is being conducted in the Philippines and has been completed.
PVRV is in Phase 3 clinical development. It is an investigational monoclonal antibody for rabies post-exposure prophylaxis. The Phase 3 trial, NCT01622062, has been completed. PVRV is not approved and remains under clinical investigation.
PVRV has one completed Phase 3 clinical trial, NCT01622062, titled "Immunogenicity and Safety of Verorab® in a 'One-week' Intradermal Post-exposure Prophylaxis Regimen." The trial enrolled 600 participants with rabies in the Philippines and was active-controlled, though not double-blinded.
PVRV is being studied in a trial that uses Verorab® as the treatment. The trial title references Verorab® in the one-week intradermal regimen. PVRV is the drug name used in the clinical development context, and Verorab is the brand name referenced in the trial.